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United States · US · US:65862-834_a583a371-730c-4f0a-86b6-01e654770f16

Amlodipine, Valsartan and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C08CA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeC08CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6586283405
    500 TABLET, FILM COATED in 1 BOTTLE (65862-834-05)
  • ndc11
    6586283430
    30 TABLET, FILM COATED in 1 BOTTLE (65862-834-30)
  • ndc11
    6586283490
    90 TABLET, FILM COATED in 1 BOTTLE (65862-834-90)

Annotations

UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A206180
ABABABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "864V2Q084H",
    "rxcui": "104416",
    "inchikey": "ZPBWCRDSRKPIDG-UHFFFAOYSA-N",
    "display_name": "AMLODIPINE BESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e9ecbadb-c548-6fe5-e053-2a95a90a7577": {
      "match": "brand_token",
      "title": "AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "3",
      "published_date": "2025-06-12"
    }
  },
  "productid": "65862-834_a583a371-730c-4f0a-86b6-01e654770f16",
  "productndc": "65862-834",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206180",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;12.5MG;160MG",
        "product_no": "001",
        "approval_date": "Dec 19, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;25MG;160MG",
        "product_no": "002",
        "approval_date": "Dec 19, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;12.5MG;160MG",
        "product_no": "003",
        "approval_date": "Dec 19, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;25MG;160MG",
        "product_no": "004",
        "approval_date": "Dec 19, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;25MG;320MG",
        "product_no": "005",
        "approval_date": "Dec 19, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
  "shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "shortage_status": "current",
  "proprietary_name": "Amlodipine, Valsartan and Hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA206180",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amlodipine, Valsartan and Hydrochlorothiazide",
  "start_marketing_date": "20171219",
  "active_numerator_strength": "5; 12.5; 160"
}

Related drugs

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